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An updated systematic review and consensus definitions for standardised endpoints in perioperative medicine: patient
Paul S Myles1, Sophie Wallace1, Oliver Boney2
1Department of Anaesthesiology and Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, VIC, Australia.
Background:
Improving comfort during and after surgery is a key concern for anaesthetists and other clinicians. With the inclusion of patient and public involvement, we undertook a Delphi consensus process to update previously recommended endpoints to be used in clinical trials evaluating treatments aiming to improve patient comfort after surgery.
Methods:
We undertook a systematic review to identify domains and outcome measures of patient comfort used in perioperative studies. Focus groups, workshops, and a multi-round Delphi consensus process that included clinician-researchers and a patient experience and consumer group updated a recommended list of standardised endpoints focused on patient comfort. Consensus was defined as a median item score of 7 or greater and at least 70% of responses achieving a score of 7 or greater on a 9-point Likert scale. Additional ratings were done to determine validity, reliability, feasibility, and patient-centredness. Qualitative analyses were undertaken to identify themes.
Results:
Response rates for each of the Delphi rounds were 100%. A final list of eight defined endpoints was identified: supplementary analgesic use, subjective analgesic effectiveness, pain intensity (at rest, during movement, and at 12, 24, and 72 h), postoperative nausea and vomiting (PONV, at 0-6 h, at 6-24 h, and overall), postdischarge nausea and vomiting (PDNV), severe PONV, quality of recovery (QoR-15), and time to mobilisation. All endpoints were assessed as valid, reliable, and feasible measures of patient comfort and were considered patient-centred. Patient and public involvement highlighted the importance of clear communication and shared decision-making to enhance comfort through the surgical journey.
Conclusions:
We recommend that at least some of these standardised endpoints be included as outcome measures in clinical trials assessing patient comfort and pain after surgery.
Systematic Review Protocol:
Open Science Framework (10.17605/OSF.IO/DJQFE).
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